Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.

The FDA Safety and Innovation Act passed the House Wednesday on a voice
vote. Consumer advocates had mixed reactions since the bill left out some
critical patient safety protections but could have been a lot worse given the
political muscle of medical industry lobbyists.

For Consumers Union, the most
disturbing issue that was left unaddressed by the bill is a dangerous loophole
in the FDA’s 510(k) clearance process, which is used to review over 90 percent
of all medical devices. By law, the FDA can only consider whether the new
device is similar to one that has already been cleared and no evidence of
clinical testing is required – even when the device it is based on is one that
has been recalled by the manufacturer due to safety problems. Representative
Ed Markey of MA introduced an amendment to prohibit recalled devices from being
used to clear new ones but opposition from
the medical device industry kept it out of the bill. We sent over
200,000 letters to Congress from their constituents and placed an ad in Politico
to draw attention to the loophole.

On the plus side, the final bill included some
stronger reforms that were included in the version of the bill
passed by the Senate earlier this year. But overall, the final bill more
closely reflects the agenda of the medical device industry than what’s needed
to protect patients. Consumers Union’s Lisa McGiffert noted:

“This bill includes some important reforms that will improve the FDA’s
ability to monitor medical devices on the market and to notify patients and
require stricter testing when safety problems arise,” said Lisa McGiffert,
director of Consumers Union’s Safe Patient
Project. “But there is clearly more work that needs to be done
to ensure that the FDA has all the tools it needs to ensure medical devices are
safe and effective before they can be used on patients.”

With little enthusiasm for Rep. Markey’s amendment, we promoted a
stripped down version amendment so the FDA would merely have the authority to
require manufacturers of new devices to prove that the new device has fixed the
flaws in a recalled predicate device that is used for clearance based on
its similarity to the flawed device. But industry lobbyists managed to block
that too.

Consumers Union found
early in the negotiations the formidable pressure on Congress from the device
industry and the need for consumer voices and advocacy organizations to promote
patient safety. We sponsored a lobby day in Washington D.C. where people who have been
harmed by faulty medical devices (surgical mesh, joint replacements and
defibrillators) lobbied their Representatives and Senators.

As the final bill was being negotiated by House and Senate leaders,
Consumers Union sent these lawmakers a story a day
about people who have been harmed by a medical device in an effort to keep the
medical device safety provisions in the bill.

Good provisions in the bill include:

▪a deadline for creating a Unique Device Identifier (UDI) system for
implants and high-risk devices. It’s extremely important that the FDA implement
a system to identify each individual device implanted in a patient so if a
device is recalled, the patient can be notified quickly.

▪gives the FDA the authority to more easily reclassify problematic
devices so that subsequent, similar devices must undergo more safety scrutiny
before they can be used on patients.

▪adds some provisions to improve post-market oversight, including adding
medical devices to the “Sentinel Initiative” which pulls together different
databases to help the FDA analyze patterns and more quickly identify safety
problems with a device.

Ultimately the law gives
the drug and device industries what they wanted: to speed up the approval of
new products, getting them on the market quicker. To counter balance the
problems with medical devices that were not identified before approval, there
are some new tools that the FDA can utilize to monitor the safety of devices
once they are on the market. Consumers
Union would rather see life-saving and implantable devices thoroughly studied
before they are allowed on the market to identify potential safety problems
that can harm patients.

Throughout the course of our campaign, we’ve encountered many advocates
who want to continue working with us to improve medical device safety. One of
them is Dwight S. from Bellevue, Washington. Next week, Dwight is going to DC
to attend an FDA advisory panel examining the safety of metal-on-metal hip
implants and will share his wife’s story about her recalled metal-on-metal hip.
The FDA received almost 16,800 adverse event reports about
metal-on-metal hip implants from 2000-2011. Stay tuned for our blog post
about the FDA meeting.

Thank you, Consumers Union, for providing this information and for
vigorous advocacy on behalf of U.S. consumers! Congress must improve
legislation on the patient harm that is imposed by such poor federal public
policy. The public is uniformed because the implanted medical device industry
does not have to provide clinical testing prior to FDA ‘approval’ or disclose post-market
information about safety and effectiveness. There are not, however, reasonable
restrictions on direct-to-consumer marketing. It is inevitable that aggressive
surgeons/device CEO’s will continue to lobby Congress for fewer restrictions
and the taxpayers and victimized consumers will be accountable for expensive
revision surgeries and a life in medical and legal purgatory.